^
Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Thyroid Gland Carcinoma |
| Drug: | Cabometyx (cabozantinib tablet) (Multi-tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Health Canada approves Ipsen’s CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory or Ineligible Differentiated Thyroid Cancer
Published date:
05/04/2022
Excerpt:
Ipsen Biopharmaceuticals Canada Inc. today announced the Health Canada approval of CABOMETYX® (cabozantinib) for the treatment of adults with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory (RAI-R) or ineligible....This approval is based on the Phase III COSMIC-311 trial, which demonstrated that CABOMETYX® showed statistically significant improvement in progression-free survival for patients vs placebo.
Source:
Title:
European Commission approves Cabometyx® as a second-line treatment for people living with radioactive iodine-refractory differentiated thyroid cancer
Published date:
05/03/2022
Excerpt:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the European Commission (EC) has approved the use of Cabometyx® (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy....Approval based on data from the COSMIC-311 Phase III trial, in which Cabometyx® (cabozantinib) demonstrated a 78% reduction in risk of disease progression or death versus placebo.
Source:
Published date:
09/17/2021
Excerpt:
CABOMETYX is a kinase inhibitor indicated for the treatment of...adult and pediatric patients 12 years of age and older with locally advanced ormetastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible...
Source:
Title:
ESMO Clinical Practice Guideline update on the use of systemic therapy in advanced thyroid cancer
Published date:
04/28/2022
Excerpt:
Recommendations...cabozantinib is an option to treat adults and adolescents aged ≥12 years with RAI-refractory advanced/metastatic DTCs that have progressed following treatment with MKIs…
DOI:
https://doi.org/10.1016/j.annonc.2022.04.009
Source:
Title:
Ipsen receives positive CHMP opinion for Cabometyx® in radioactive iodine-refractory differentiated thyroid cancer
Published date:
03/25/2022
Excerpt:
Ipsen...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) have recommended approval of Cabometyx as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC)...The CHMP positive opinion was based on results from the pivotal COSMIC-311 Phase III trial in which, at a planned interim analysis with a median follow-up of 6.2 months, Cabometyx demonstrated a significant reduction in the risk of disease progression or death by 78% versus placebo (hazard ratio [HR]: 0.22; 96% confidence interval [CI]: 0.13-0.36; p<0.0001).
Trial ID:
Source:
Title:
Exelixis Announces U.S. FDA Accepts for Priority Review the Supplemental New Drug Application for CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Published date:
08/05/2021
Excerpt:
Exelixis, Inc....today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for CABOMETYX (cabozantinib) as a treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate). The FDA granted Priority Review designation and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021.
Source:
Title:
Cabozantinib versus placebo in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after prior VEGFR-targeted therapy: Results from the phase 3 COSMIC-311 trial.
Published date:
05/28/2021
Excerpt:
This phase 3 study (NCT03690388) evaluated the efficacy and safety of C vs placebo (P) in pts with RAI-refractory DTC...ORR was 15% for C vs 0% for P (p = 0.0281) but did not meet the prespecified criteria for statistical significance (p < 0.01). A favorable OS trend was observed for C vs P (HR 0.54, 95% CI 0.27–1.11)....C showed a clinically and statistically significant improvement in PFS over P in pts with RAI-refractory DTC...
DOI:
10.1200/JCO.2021.39.15_suppl.6001
Trial ID:
Source:
Title:
Exelixis Announces Breakthrough Therapy Designation Granted to Cabozantinib for the Treatment of Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Published date:
02/25/2021
Excerpt:
Exelixis, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to cabozantinib (CABOMETYX) as a potential treatment for patients with differentiated thyroid cancer (DTC) that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
